investigation of milk peptides (pep2dia®) on postprandial blood glucose profile in prediabetic subjects

Conditions: Prediabetic State

Summary: the goal is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of pep2dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. pep2dia® will be administered 15 min prior to a standardized challenge meal.

from a previous pilot study (bts1130/17) there is first evidence that the native whey product with alpha-glucosidase inhibiting properties (pep2dia®) has the potential to modulate postprandial hyperglycaemia in prediabetic subjects. thereby, incremental areas under the curve (iauc) of glucose as the primary outcome were significantly reduced by a single dosage of 1400 mg pep2dia® compared to placebo the second study is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of pep2dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. pep2dia® will be administered 15 min prior to a standardized challenge meal. furthermore, the 120 min postprandial incretin response in terms of glucagon-like peptide-1 (glp-1) will be determined. changes in insulin sensitivity will be determined by the matsuda-index as appropriate outcome measure.

Eligibility criteria:
inclusion criteria: * male and female subjects (minimum one third of each gender) with prediabetic hba1c values between 5.7% - 6.4% and/or fasting glucose ≥ 5.6 mmol/l (≥ 100 mg/dl) and \< 7.0 mmol/l (\< 125 mg/dl) (in venous plasma) (twice confirmed at two independent days if hba1c is \< 5.7%) * body mass index 19-35 kg/m2 * non-smoker * caucasian * availability and presence in the study units for approx. 3.5 hours/ week for 3 times. * signed informed consent form * no changes in food habits or physical activity 3 months prior to screening and during the study exclusion criteria: * presence of disease or drug(s) influencing digestion and absorption of nutrients or bowel habits * intake of medications known to affect glucose tolerance, e.g., diabetic medication, steroids, protease inhibitors or antipsychotics * diagnosed typ 2-diabetics with medical treatment * chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the investigator's opinion would impact patient safety * severe liver, renal or cardiac disease * acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks * known inflammatory and malignant gastrointestinal diseases (i.e. colitis ulcerosa, morbus crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis) * clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs * major medical or surgical event requiring hospitalization within the previous 3 months * intake of antibiotics within 4 weeks before the test days * known alcohol abuse or drug abuse * pregnant or breast feeding women * known or suspected allergy to any component of the investigational product(s) (e.g. milk protein) * known hiv-infection * known acute or chronic hepatitis b and c infection * blood donation within 4 weeks prior to visit 1 or during the study * subject unable to co-operate adequately